Senior Director, PV Process Lead

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Job Description

The Senior Director, Pharmacovigilance (PV) Process Lead:

• Owns designated end-to-end (E2E) pharmacovigilance (PV) processes for critical cross-functional areas, setting the strategy, accountability, and oversight to ensure consistent execution, in alignment with regulatory requirements.
• Cultivates trusted, enterprise-wide relationships with key stakeholders across Takeda (e.g., Regulatory, Quality Assurance, Global Development Operations, Clinical Science, Medical Affairs, Commercial, Local Operating Companies, DD&T), demonstrating executive presence and strategic influence while serving as the central orchestrator to ensure strong PV oversight and performance, identifying risks, driving issue resolution, and promoting alignment and decision-making among cross-functional stakeholders.
• Drives continuous process improvement, operational excellence, and efficiency by leveraging technology and AI-enabled capabilities to enable streamlined, compliant, and inspection ready E2E processes with clear roles and responsibilities.

By driving governance, alignment, and execution across critical cross-functional PV processes, this role delivers enterprise-level impact. With strong partnerships and a continuous improvement and technology/digital mindset, the PV Process Lead enables the organization to deliver on key priorities, operational excellence, and advance patient safety across the business globally.

The PV Process Lead is accountable for the strategy, direction, and implementation of end-to-end processes to ensure they are in line with health authority PV requirements and deliver on key priorities.

The PV Process Lead:

• Serves as the enterprise process owner and central orchestrator for E2E PV processes, building and sustaining trusted relationships with senior cross-functional stakeholders, driving alignment, decision-making, and accountability across the organization.
• Drives cross-functional governance and operational excellence by defining roles, decision accountability, and forums that enable collaboration, transparency, and effective execution.
• Owns the design, procedural documentation, implementation, management, and oversight of designated E2E PV processes, with scope expanding to other E2E processes, as needed.
• Develops, authors, maintains, and approves procedural documents, associated templates/forms, training materials, and other toolkits for designated E2E PV processes. Provides input to associated procedural documents owned by sub-functions in relation to designated E2E PV processes.
• Provides E2E PV oversight for designated processes by proactively identifying risks, trends, and gaps, and ensuring timely escalation, resolution, and mitigation in line with regulatory expectations.
• Serves as the main point of contact for Quality Events, CAPAs, and Change Controls related to the designated processes, and represents those E2E processes during audits and health authority inspections.
• Contributes to process impact assessments in response to changes in PV regulatory requirements identified through Takeda’s regulatory intelligence activities and oversees implementation of the necessary updates to ensure these processes comply with new regulatory requirements.
• Champions technology and AI-enabled capabilities to drive continuous process improvement, operational excellence, and efficiency by streamlining the E2E processes, defining clear roles and responsibilities, and ensuring that they are in-line with regulatory requirements to maintain inspection readiness at all time.
• Provides support and back-up for other designated E2E PV processes, as needed, to ensure continuity, quality, and timely execution.
• Performs other duties as requested by management.

The PV Process Lead has:

• Deep PV knowledge and subject matter expertise on designated E2E PV processes
• Deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines with extensive understanding of pharmacovigilance processes
• Comprehensive understanding of the pharmaceutical industry and PV compliance
• Good analytical/judgement and critical thinking capabilities to understand, analyze, synthesize, and communicate
• Project management skills, including ability to manage time and multiple priorities
• Enterprise-level leadership with the ability to inspire, influence, motivate, and drive results
• Demonstrated ability to work across functions, regions, and cultures, and capable of reconciling conflicting views into a cohesive path forward
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company

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